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Soy Food and Coronary Heart Disease in Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00241735
Enrollment
135896
Registered
2005-10-19
Start date
2005-09-01
Completion date
2009-05-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Brief summary

To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI) and fatal coronary heart disease in Chinese women.

Detailed description

BACKGROUND: Coronary heart disease (CHD) is the leading cause of death in the US and many other countries. Estrogen deficiency plays a significant role in the development of coronary heart disease (CHD) in postmenopausal women. Recently, a series of randomized clinical trials evaluating the effects of hormone replacement therapy (HRT) on CHD yielded surprisingly deleterious results, shifting clinical decision-making from a position of presumed benefit to one of potential harm. Soy food is emerging as a promising natural substitute for HRT, given its estrogenic properties and potential lipids benefits. However, data directly linking soy food intake to the clinical endpoints of CHD are lacking. DESIGN NARRATIVE: The study will evaluate the association of soy food consumption with CHD using resources from the Shanghai Women's Health Study (SWHS), an ongoing prospective cohort study of 75,000 Chinese women who were recruited from 1997 to 2000 and who completed two extensive dietary assessments at baseline. The investigators will verify all CHD events identified in this cohort during the follow-up and longitudinally analyze the association between soy food intake and CHD risk, overall, and according to conventional CHD risk factors. In addition, they will conduct a nested case-control study to evaluate the association of urinary isoflavonoids (a biomarker of soy intake) and risk of CHD, and to investigate whether soy and CHD associations are modified by baseline levels of lipids and plasma C-reactive protein, two well established risk markers of CHD. In the United States, the sale of soy products has increased more than 3-fold in recent decades, and the proportion of people reporting soy product consumption at least once a week nearly doubled in the last six years. However, the overall intake level of soy food in the US population is still low, and women who consume soy food regularly are likely to be highly selective. Furthermore, it is difficult, if at all possible, to assess usual soy food intake in the US population because soy protein is added to many American food products. Informative studies on the association between soy food intake and CHD risk are better conducted in Chinese and other Asian populations, where soy food is part of traditional dietary practice. The SWHS with its wealth of data on dietary and lifestyle factors and biological samples provides a unique and unparalleled opportunity to prospectively investigate the effects of soy food intake on the risk of CHD, and to identify those most likely to benefit from consumption of soy food.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

All women 40-70 years of age and living in the study communities

Contacts

PRINCIPAL_INVESTIGATORXiao Shu

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026